Approvals/TGA/DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 200 microgram / 6 microgram powder for inhalation dry powder inhaler

Approved

STANDARD

DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 200 microgram / 6 microgram powder for inhalation dry powder inhaler

Teva Pharma Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 8aeb86dfca30f430
Product Name: DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 200 microgram / 6 microgram powder for inhalation dry powder inhaler
Artg Id: 267385
Artg Name: DUORESP SPIROMAX budesonide / formoterol fumarate dihydrate 200 microgram / 6 microgram powder for inhalation dry powder inhaler
Sponsor: Teva Pharma Australia Pty Ltd
Company Detail Path: /organization/teva-pharma-australia-pty-ltd
Artg Date: 2016-12-19
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/56b53a038f1a9d346ee735f2915dd05d.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ce700bc80d070485b1a3caeca333664f.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

8aeb86dfca30f430

Type

Standard